FDA’s Dosage and Administration Section of Labeling Draft Guidance Day 2 

In this video, FDA discusses the following topic in the draft guidance for industry: Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products - Content and Format. Day 2 Topic: Dosage Modifications and Preparation- and Administration-Related Information in Labeling.
Timestamps
00:24 - Dosage and Administration Section of Labeling: Part 2 of 2
06:30 - Administration Instructions Included with the Recommended Dosage
18:25 - Recommended Monitoring for Effectiveness
21:07 - Other Therapy Used Prior to Subject Drug Use and Concomitant Therapy
25:14 - Dosage Modifications
27:19 - Dosage Modifications Intended to Reduce the Risk of Adverse Reactions
31:47 - Dosage Modifications for Drug Interactions
38:27 - Recommendations for Drug Discontinuation When There Are Withdrawal Risks
40:03 - Preparation Instructions
44:32 - Preparation and Administration Instructions for Certain Products
48:54 - Storage Instructions for the Prepared Product
56:28 - Q&A Discussion
Speaker:
Eric Brodsky, M.D.
Associate Director, Labeling Policy Team
Office of New Drug Policy (ONDP)
Office of New Drugs (OND) | CDER | FDA
Panelist:
Eric Brodsky, M.D.
Learn more at: www.fda.gov/drugs/news-events...
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